Department of Lymphatic and Reconstructive Surgery, JR Tokyo General Hospital, Tokyo, Japan.
Department of Lymphatic and Reconstructive Surgery, Saiseikai Kawaguchi General Hospital, Saitama, Japan.
Br J Surg. 2024 Jan 3;111(1). doi: 10.1093/bjs/znad372.
Lymphatic venous anastomosis is associated with a low incidence of lower extremity lymphoedema-associated cellulitis; however, the exact relationship is unknown. This multicentre RCT evaluated the effect of lymphatic venous anastomosis on prevention of cellulitis.
Patients with secondary lower extremity lymphoedema who underwent at least 3 months of non-operative decongestive therapy were assigned randomly to lymphatic venous anastomosis or conservative therapy. The primary and secondary outcomes were cellulitis frequency, and assessments of circumference, hardness, and pain respectively.
Overall, 336 patients were divided into two groups: 225 in the full-analysis set (primary outcome 225; secondary outcomes 170) and 156 in the per-protocol set (primary outcome 156; secondary outcomes 110). In both analyses, lymphatic venous anastomosis with non-operative decongestive therapy was more effective in preventing cellulitis than non-operative decongestive therapy alone; the difference between groups in reducing cellulitis frequency over 6 months was -0.35 (95 per cent c.i. -0.62 to -0.09; P = 0.010) in the full-analysis set (FAS) and -0.60 (-0.94 to -0.27; P = 0.001) in the per-protocol set (PPS) Limb circumference and pain were not significantly different, but lymphatic venous anastomosis reduced thigh area hardness (proximal medial and distal and lateral proximal). Four patients experienced contact dermatitis with non-operative decongestive therapy alone.
Lymphatic venous anastomosis in combination with non-operative decongestive therapy prevents cellulitis.
UMIN00025137, UMIN00031462.
淋巴管静脉吻合术与下肢淋巴水肿相关蜂窝织炎的低发病率相关；然而，确切的关系尚不清楚。这项多中心 RCT 评估了淋巴管静脉吻合术对预防蜂窝织炎的效果。
接受至少 3 个月非手术减压治疗的继发性下肢淋巴水肿患者被随机分配至淋巴管静脉吻合术或保守治疗组。主要和次要结局分别为蜂窝织炎发生率，以及周长、硬度和疼痛评估。
共有 336 名患者被分为两组：全分析集（主要结局 225 例；次要结局 170 例）和方案集（主要结局 156 例；次要结局 110 例）各 156 名患者。在两种分析中，与非手术减压治疗相比，淋巴管静脉吻合术联合非手术减压治疗更能有效预防蜂窝织炎；在 6 个月内，组间减少蜂窝织炎发生率的差异在全分析集（FAS）中为 -0.35（95%置信区间 -0.62 至 -0.09；P = 0.010），在方案集（PPS）中为 -0.60（-0.94 至 -0.27；P = 0.001）。肢体周长和疼痛无显著差异，但淋巴管静脉吻合术降低了大腿区域的硬度（近端内侧和远端以及外侧近端）。有 4 名患者单独接受非手术减压治疗时出现接触性皮炎。
淋巴管静脉吻合术联合非手术减压治疗可预防蜂窝织炎。
UMIN00025137，UMIN00031462。
